Interscalene Block Versus Infraclavicular Block Plus Suprascapular Nerve Block (ISBvsICB-SSB)
Primary Purpose
Shoulder Injury
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Interscalene block
Infraclavicular-suprascapular block
Sponsored by
About this trial
This is an interventional supportive care trial for Shoulder Injury
Eligibility Criteria
Inclusion Criteria:
- age between 18 and 75 years
- American Society of Anesthesiologists classification 1-3
- body mass index between 20 and 30
Exclusion Criteria:
- adults who are unable to give their own consent
- pre-existing neuropathy (assessed by history and physical examination)
- coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- obstructive or restrictive pulmonary disease (assessed by history and physical examination)
- renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- allergy to local anesthetics (LAs)
- pregnancy
- prior surgery in the neck, infraclavicular region or suprascapular fossa
- chronic pain syndromes requiring opioid intake at home
Sites / Locations
- Hospital Clinico Universidad de Chile
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Interscalene block
Diaphragm-sparing block
Arm Description
Ultrasound guided Brachial plexus block injecting 20 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml, in the Interscalene groove.
Ultrasound guided combinated infraclavicular-Suprascapular block of the braquial plexus, injecting 20 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml dorsal to the axillary artery in the infraclavicular fossa plus an Ultrasound guided injection of 10 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml in the suprascapular fossa.
Outcomes
Primary Outcome Measures
Static Pain using numeric scale 0-10
Secondary Outcome Measures
Static Pain using numeric scale 0-10
Diaphragm paralysis incidence
Static Pain using numeric scale 0-10
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02993939
Brief Title
Interscalene Block Versus Infraclavicular Block Plus Suprascapular Nerve Block
Acronym
ISBvsICB-SSB
Official Title
A Randomized Comparison Between Interscalene Brachial Plexus Block and Combined Infraclavicular Brachial Plexus Block-Suprascapular Nerve Block
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
April 28, 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Despite their reliability and efficacy for shoulder surgery analgesia, above clavicle brachial plexus blocks are related with phrenic nerve palsy and diaphragm paralysis that may not be tolerated in patients with chronic pulmonary disease.
This RCT will compare the classic Interscalene block with combined infraclavicular block plus suprascapular nerve block in patients going for arthroscopic shoulder surgery.
Main outcome is static pain in the recovery room measured with NRS. Secondary outcomes are pain at 12 and 24 hrs and incidence of diaphragmatic paralysis.
Detailed Description
PATIENT RECRUITMENT
With the approval of the Ethics Committee of Hospital Clinico Universidad de Chile, 40 patients undergoing arthroscopic shoulder surgery will be recruited. Enrollment will be carried out by an investigator not involved in patient care. Patients' confidentiality will be protected.
STUDY PROTOCOL: GENERAL
All blocks will be performed by one of the coauthors and conducted preoperatively in an induction room. Sedation (2 mg midazolam and 50 μg fentanyl) will be provided for patient comfort.
STUDY PROTOCOL: PERFORMANCE OF THE BLOCK
Both study groups will receive an ultrasound-guided superficial cervical plexus block.
In the ICB-SSB group, suprascapular nerve blocks will be carried out using a previously described technique. For infraclavicular brachial plexus blocks, 20 mL of levobupivacaine 0.25% with epinephrine 5 µg/mL will be injected dorsal to the axillary artery, medial to the coracoid process.
In the ISB group, block will carried out using a previously described technique: 20 mL of levobupivacaine 0.25% with epinephrine 5 µg/mL will be deposited under the prevertebral fascial between the C5 and C6 roots.
STUDY PROTOCOL: GENERAL ANESTHESIA
All patients will undergo standardized general anesthesia
STUDY PROTOCOL: POSTOPERATIVE ANALGESIA
In the Recovery Room, all patients will receive acetaminophen (usual dose…) and ketoprofen (usual dose…) as well as patient controlled analgesia (morphine bolus = 1 mg; lockout interval = 8 minutes). On the surgical ward, all subjects will continue to receive acetaminophen (usual dise…), celecoxib (usual dose…) as well and patient controlled analgesia (morphine bolus = 1 mg IV; lockout interval = 8 minutes).
STUDY PROTOCOL: OUTCOME MEASUREMENTS
The primary outcome will be the pain score in the PACU at 30 30 minutes using a sensorimotor composite scale:
Performance time, sensorimotorSensory function, Onset time
The blinded investigator will also assess the presence of hemidiaphragmatic block at 30 minutes. A 2-6 MHz curvilinear US probe (Sonosite M-Turbo, SonoSite Inc, Bothell, WA, USA) and the M-mode will be employed in all subjects; the liver and spleen will serve as acoustic windows on the right and left side, respectively. Patients will be scanned along the anterior axillary line and the US probe, angled cranially
POTENTIAL BENEFITS OF THE STUDY This study will allow us to determine if ICB-SSB constitutes a viable alternative to ISB.
POTENTIAL SIDE EFFECTS OF THE STUDY Participation in this protocol will not put patients at higher risk for complications since ISB and ICB-SSB are commonly used to provide analgesia for shoulder surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Injury
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interscalene block
Arm Type
Active Comparator
Arm Description
Ultrasound guided Brachial plexus block injecting 20 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml, in the Interscalene groove.
Arm Title
Diaphragm-sparing block
Arm Type
Experimental
Arm Description
Ultrasound guided combinated infraclavicular-Suprascapular block of the braquial plexus, injecting 20 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml dorsal to the axillary artery in the infraclavicular fossa plus an Ultrasound guided injection of 10 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml in the suprascapular fossa.
Intervention Type
Procedure
Intervention Name(s)
Interscalene block
Intervention Description
Ultrasound guided single shot block above the clavicle
Intervention Type
Procedure
Intervention Name(s)
Infraclavicular-suprascapular block
Intervention Description
Combined block of nerves far away from phrenic nerve
Primary Outcome Measure Information:
Title
Static Pain using numeric scale 0-10
Time Frame
30 minutes after arrival to PACU
Secondary Outcome Measure Information:
Title
Static Pain using numeric scale 0-10
Time Frame
12 hrs after arrival to PACU
Title
Diaphragm paralysis incidence
Time Frame
30 minutes after block
Title
Static Pain using numeric scale 0-10
Time Frame
24 hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age between 18 and 75 years
American Society of Anesthesiologists classification 1-3
body mass index between 20 and 30
Exclusion Criteria:
adults who are unable to give their own consent
pre-existing neuropathy (assessed by history and physical examination)
coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
obstructive or restrictive pulmonary disease (assessed by history and physical examination)
renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
allergy to local anesthetics (LAs)
pregnancy
prior surgery in the neck, infraclavicular region or suprascapular fossa
chronic pain syndromes requiring opioid intake at home
Facility Information:
Facility Name
Hospital Clinico Universidad de Chile
City
Santiago
State/Province
Metropolitan
ZIP/Postal Code
8380456
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19282714
Citation
Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb. Erratum In: Reg Anesth Pain Med. 2010 Jul-Aug;35(4):407.
Results Reference
result
PubMed Identifier
2006740
Citation
Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
Results Reference
result
PubMed Identifier
12606927
Citation
Martinez J, Sala-Blanch X, Ramos I, Gomar C. Combined infraclavicular plexus block with suprascapular nerve block for humeral head surgery in a patient with respiratory failure: an alternative approach. Anesthesiology. 2003 Mar;98(3):784-5. doi: 10.1097/00000542-200303000-00031. No abstract available.
Results Reference
result
PubMed Identifier
20975470
Citation
Tran DQ, Dugani S, Finlayson RJ. A randomized comparison between ultrasound-guided and landmark-based superficial cervical plexus block. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):539-43. doi: 10.1097/AAP.0b013e3181faa11c.
Results Reference
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PubMed Identifier
21654552
Citation
Chan CW, Peng PW. Suprascapular nerve block: a narrative review. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):358-73. doi: 10.1097/AAP.0b013e3182204ec0.
Results Reference
result
PubMed Identifier
20048654
Citation
Tran DQ, Bertini P, Zaouter C, Munoz L, Finlayson RJ. A prospective, randomized comparison between single- and double-injection ultrasound-guided infraclavicular brachial plexus block. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):16-21. doi: 10.1097/AAP.0b013e3181c7717c.
Results Reference
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PubMed Identifier
21568985
Citation
Spence BC, Beach ML, Gallagher JD, Sites BD. Ultrasound-guided interscalene blocks: understanding where to inject the local anaesthetic. Anaesthesia. 2011 Jun;66(6):509-14. doi: 10.1111/j.1365-2044.2011.06712.x.
Results Reference
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PubMed Identifier
27396247
Citation
Flohr-Madsen S, Ytrebo LM, Valen K, Wilsgaard T, Klaastad O. A randomised placebo-controlled trial examining the effect on hand supination after the addition of a suprascapular nerve block to infraclavicular brachial plexus blockade. Anaesthesia. 2016 Aug;71(8):938-47. doi: 10.1111/anae.13504.
Results Reference
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PubMed Identifier
16331304
Citation
Lloyd T, Tang YM, Benson MD, King S. Diaphragmatic paralysis: the use of M mode ultrasound for diagnosis in adults. Spinal Cord. 2006 Aug;44(8):505-8. doi: 10.1038/sj.sc.3101889. Epub 2005 Dec 6.
Results Reference
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PubMed Identifier
27380105
Citation
Dhir S, Sondekoppam RV, Sharma R, Ganapathy S, Athwal GS. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Nerve Block for Analgesia in Arthroscopic Shoulder Surgery: An Equivalence Study. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):564-71. doi: 10.1097/AAP.0000000000000436.
Results Reference
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PubMed Identifier
29270914
Citation
Aliste J, Bravo D, Finlayson RJ, Tran DQ. A randomized comparison between interscalene and combined infraclavicular-suprascapular blocks for arthroscopic shoulder surgery. Can J Anaesth. 2018 Mar;65(3):280-287. doi: 10.1007/s12630-017-1048-0. Epub 2017 Dec 19.
Results Reference
derived
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Interscalene Block Versus Infraclavicular Block Plus Suprascapular Nerve Block
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